Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Recall
- Recall Number
- Z-0389-2022
- Event Number
- 88545
- Firm
- Xstrahl Limited
- FEI Number
- 3004561814
- Product Code
- JAD
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- August 27, 2021
- Terminated
- March 4, 2026
- Address
- Maybrook Industrial Estate Maybro; Maybrook Road Walsall United Kingdom Unit 2
Description
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Base plate may detach from the main body of the treatment applicator.
The firm notified their consignees by email on 08/27/2021. The notice requested the following actions be taken: Xstrahl Limited are issuing the following inspection advice for all X150 specifical system users. 1. Prior to any clinical exposure the operator of the system should inspect the treatment applicator prior to inserting it into the treatment head of the X150. 2. As part of the daily assurance process the treatment applicators should be inspected. 3. If a treatment applicator is dropped it should be inspected by medical physics to ensure it is not damaged. 4. If the base plate is missing the applicators must be withdrawn from clinical use until it is repaired and accepted by medical physics. 5. In the case of an applicator where the base plate has become detached, review the prescription history for the patients for whom that applicator was prescribed. 6. Please advise Xstrahl Limited if you believe patients have been treated with a base plate missing, with detail of the applicator size and clinical filter, kV and HVL, and we will contact you directly.
US and ALGERIA, AUSTRALIA, AUSTRIA, BULGARIA, CANADA, COSTA RICA, CROATIA, CYPRUS, DENMARK, FRANCE, GERMANY, HONG KONG, IRELAND, ITALY, KAZAKHSTAN, LATVIA, MALTA, MEXICO, NEW ZEALAND, NORWAY, PANAMA, ROMANIA, RUSSIA, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, UK, UKRAINE
120 applicators